Application Sponsors
Marketing Status
Over-the-counter | 001 |
Over-the-counter | 002 |
Application Products
001 | TABLET;ORAL | 10MG | 0 | FAMOTIDINE | FAMOTIDINE |
002 | TABLET;ORAL | 20MG | 0 | FAMOTIDINE | FAMOTIDINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-01-28 | STANDARD |
Submissions Property Types
CDER Filings
VKT PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 215822
[companyName] => VKT PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)